Delivery device and methods of use for transapical delivery of replacement mitral valve

ABSTRACT

Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/210,302, filed Aug. 26, 2015, tilted “PROSTHESIS, DELIVERY DEVICE ANDMETHODS OF USE”, the entirety of which is incorporated herein byreference.

BACKGROUND

Field

Certain embodiments disclosed herein relate generally to prostheses forimplantation within a lumen or body cavity and delivery devices for aprosthesis. In particular, the prostheses and delivery devices relate insome embodiments to replacement heart valves, such as replacement mitralheart valves.

Description of the Related Art

Human heart valves, which include the aortic, pulmonary, mitral andtricuspid valves, function essentially as one-way valves operating insynchronization with the pumping heart. The valves allow blood to flowdownstream, but block blood from flowing upstream. Diseased heart valvesexhibit impairments such as narrowing of the valve or regurgitation,which inhibit the valves' ability to control blood flow. Suchimpairments reduce the heart's blood-pumping efficiency and can be adebilitating and life threatening condition. For example, valveinsufficiency can lead to conditions such as heart hypertrophy anddilation of the ventricle. Thus, extensive efforts have been made todevelop methods and apparatuses to repair or replace impaired heartvalves.

Prostheses exist to correct problems associated with impaired heartvalves. For example, mechanical and tissue-based heart valve prosthesescan be used to replace impaired native heart valves. More recently,substantial effort has been dedicated to developing replacement heartvalves, particularly tissue-based replacement heart valves that can bedelivered with less trauma to the patient than through open heartsurgery. Replacement valves are being designed to be delivered throughminimally invasive procedures and even percutaneous procedures. Suchreplacement valves often include a tissue-based valve body that isconnected to an expandable frame that is then delivered to the nativevalve's annulus.

Development of prostheses including but not limited to replacement heartvalves that can be compacted for delivery and then controllably expandedfor controlled placement has proven to be particularly challenging. Anadditional challenge relates to the ability of such prostheses to besecured relative to intralumenal tissue, e.g., tissue within any bodylumen or cavity, in an atraumatic manner.

Delivering a prosthesis to a desired location in the human body, forexample delivering a replacement heart valve to the mitral valve, canalso be challenging. Obtaining access to perform procedures in the heartor in other anatomical locations may require delivery of devicespercutaneously through tortuous vasculature or through open or semi-opensurgical procedures. The ability to control the deployment of theprosthesis at the desired location can also be challenging.

SUMMARY

Embodiments of the present disclosure are directed to a prosthesis, suchas but not limited to a replacement heart valve. Further embodiments aredirected to delivery systems, devices and/or methods of use to deliverand/or controllably deploy a prosthesis, such as but not limited to areplacement heart valve, to a desired location within the body. In someembodiments, a replacement heart valve and methods for delivering areplacement heart valve to a native heart valve, such as a mitral valve,are provided.

The present disclosure includes, but is not limited to, the followingnumbered embodiments.

Embodiment 1: A delivery system for controlled deployment of acollapsible implant, the delivery system comprising a handle at aproximal end of the delivery system, the handle comprising a tethercontrol knob configured to control movement of a tether extendingdistally away from the handle, and an outer hollow member operablyconnected to the handle configured to at least partially restrain theimplant in a collapsible configuration, wherein the tether extendsthrough the outer hollow member to engage the implant when the implantis positioned within the outer hollow member, the outer hollow memberbeing moveable relative to the implant to expose the implant at a bodylocation while the tether keeps the implant radially restrained, whereinrotation of the tether control knob in a single direction first providesslack to the tether to controllably expand the implant at the bodylocation, and continued rotation of the tether control knob in thesingle direction retracts the tether towards the handle.

Embodiment 2: The delivery system of Embodiment 1, wherein the tether isconfigured to unspool and spool in a cavity within the tether controlknob.

Embodiment 3: The delivery system of any one of Embodiments 1-2, furthercomprising a replacement valve located within a distal portion of theouter hollow member, wherein the tether wraps around the replacementvalve to prevent expansion of the replacement valve.

Embodiment 4: The delivery system of any one of Embodiments 1-3, furthercomprising a tether retention member located proximal to where thetether engages the implant, the tether retention member configured tohold a free end of the tether.

Embodiment 5: The delivery system of Embodiment 4, wherein the tetherretention member comprises a c-lock provided on an inner shaft extendingthrough the outer hollow member, the c-lock having a longitudinal slotcovered by a locking shaft slidable over the inner shaft, the slotretaining the free end of the tether.

Embodiment 6: The delivery system of Embodiment 5, wherein rotation ofthe tether control knob translates the locking shaft proximally awayfrom the c-lock to release the free end of the tether.

Embodiment 7: The delivery system of any one of Embodiments 5-6, whereina proximal end of the locking shaft is operably connected to a blocklocated within the handle and proximal of the tether knob, and rotationof the tether knob translates a screw proximally to abut and translatethe block proximally.

Embodiment 8: The delivery system of any one of Embodiments 5-7, furthercomprising a centering ring on the locking shaft to center the lockingshaft within the outer hollow member, the centering ring comprising atleast one aperture through which the tether passes.

Embodiment 9: The delivery system of any one of Embodiments 1-8, whereinthe handle comprises an auditory or visual indicator to provide a user asignal indicating a position of the tether.

Embodiment 10: A delivery system for controlled deployment of acollapsible implant, the delivery system comprising a handle comprisingan outer housing and a sleigh located at least partially within theouter housing, a first elongate shaft operably connected to the housingand configured to cover at least a proximal end of the collapsibleimplant, a second elongate shaft located within the first elongate shaftand operably connected to the sleigh, a third elongate shaft locatedwithin the second elongate shaft and operably connected to the sleigh, afourth elongate shaft located within the third elongate shaft and havinga nose cone on a distal end thereof, the nose cone configured toradially restrain a distal end of the collapsible implant, the fourthelongate shaft is operably connected to the sleigh, wherein the sleighis configured to translate relative to the housing from a distal to aproximal position, wherein translation of the sleigh from the distal tothe proximal position translates the second, third, and fourth elongateshafts proximally so that the second, third, and fourth elongate shaftsremain in the same position relative to one another in the distal andproximal position.

Embodiment 11: The delivery system of Embodiment 10, wherein the handlecomprises a sleigh lock configured to prevent motion of the sleigh uponactivation of the lock.

Embodiment 12: The delivery system of any one of Embodiments 10-11,further comprising a first shaft knob configured to translate the firstelongate shaft distally and proximally, a second shaft knob configuredto translate the second elongate shaft distally and proximally, and afourth shaft knob configured to translate the fourth shaft distally andproximally, wherein each of the shaft knobs can move their respectiveshafts independent of one another.

Embodiment 13: The delivery system of any one of Embodiments 10-12,wherein the sleigh extends proximally from the handle in the proximalposition.

Embodiment 14: A method of controllably releasing an implant from acollapsed configuration to an expanded configuration, the methodcomprising delivering an implant to an in situ target location while theimplant is in a radially compacted state within an outer member of adelivery system, the implant comprising a first end, a second end, and alongitudinal axis extending between the first and second ends, wherein atether encircles at least a portion of the implant, the tetherconfigured to restrain the radial dimension of the implant, at leastpartially removing the outer member from the implant, wherein the tetherrestrains the radial dimension of the implant after the outer member isat least partially removed, rotating a tether knob in a handle of thedelivery system in a first direction to loosen the tether encirclingimplant to cause at least the second end of the implant to controllablyexpand, rotating the tether knob in the first direction to release afree end of the tether, and rotating the tether knob in the firstdirection to remove the tether from the implant and to retract the freeend of the tether proximally towards the handle.

Embodiment 15: The method of Embodiment 14, wherein the delivery systemfurther comprises a locking shaft located within the outer member, aninner retention shaft located within the locking shaft, wherein an innerretention member is provided at a distal end of the inner retentionshaft and a tether retention member is provided on the inner retentionshaft proximal to the inner retention member, and a nose cone shaftlocated within the inner retention shaft and having a nose cone on adistal end of the nose cone shaft configured to radially restrain thefirst end of the implant.

Embodiment 16: The method of Embodiment 15, further comprising rotatinga nose cone knob on the handle to move the nose cone distally to releasethe first end of the implant to cause the implant to expand to a fullyexpanded state.

Embodiment 17: The method of any one of Embodiments 15-16, whereinrotating the tether knob moves the locking shaft proximally to uncoverthe tether retention member.

Embodiment 18: The method of any one of Embodiments 15-17, furthercomprising pulling the nose cone, nose cone shaft, inner retentionmember, and inner retention member through the implant after the implanthas been expanded.

Embodiment 19: The method of Embodiment 18, wherein the nose cone, nosecone shaft, inner retention member, and inner retention member arepulled through the implant while staying in the same relative positionto one another.

Embodiment 20: The method of any one of Embodiments 14-19, wherein theimplant comprises a replacement mitral valve comprising ventricularanchors and atrial anchors, wherein the ventricular anchors extendproximally toward the handle when the implant is an radially compactedstate when covered by the outer member and restrained by the tether, andflip to extend distally when uncovered by the outer member.

Embodiment 21: The method of any one of Embodiments 14-19, wherein theimplant is delivered to a native mitral valve through an aperture formedin an apex of a heart into the left ventricle.

Embodiment 22: A delivery system for controlled deployment of areplacement valve, such as a replacement mitral valve, the deliverysystem comprising a nose cone shaft having a proximal end and a distalend, a nose cone connected to the distal end of the nose cone shaft,wherein the nose cone comprises a proximally-facing opening to receiveat least a first end of the replacement valve, an inner retention shafthaving a proximal end and a distal end, the inner retention shaft beingslidable over the nose cone shaft, an inner retention member connectedto the distal end of the inner retention shaft, the inner retentionmember configured to engage the first end of the replacement valve, atether retention member on the inner retention shaft positioned proximalto the inner retention member, a locking shaft having a proximal end anda distal end, the locking shaft being slidable over the inner retentionshaft, wherein the locking shaft is configured to cooperate with thetether retention member to releasably engage a tether attached to thereplacement valve, a centering ring located on the locking shaft andhaving a plurality of circumferentially-spaced apertures, each apertureconfigured to receive the tether, an outer elongate hollow member havinga proximal end and a distal end, the outer elongate hollow member beingslidable over the locking shaft, wherein the outer elongate hollowmember is configured to cover at least the second end of the replacementvalve when the first end of the replacement valve is engaged with theinner retention member and is covered by the nose cone, wherein theouter elongate hollow member is moveable relative to the nose cone touncover the second end of the replacement valve while the first end ofthe replacement valve remains engaged to the inner retention ring and iscovered by the nose cone, a tether having a free end configured toengage the tether retention member when the tether retention member iscovered by the locking shaft, the tether extending distally from thetether retention member when the replacement valve is covered by theouter elongate hollow member and the nose cone to engage at least aportion of the replacement valve, the tether configured to extendproximally from the replacement valve through one of the apertures inthe centering ring, and a handle configured to translate the nose coneshaft, the inner retention shaft, the locking shaft, and the outerelongate hollow member, the handle comprising a housing, a first knobconfigured to rotate to cause translation of the outer elongate hollowmember proximally relative to the nose cone to uncover the second end ofthe replacement valve, a second knob configured to rotate to causetranslation of the tether, wherein rotation of the knob in a singledirection causes the tether to first unwind from a spool and then to bewound onto the spool, wherein unwinding of the tether from the spoolcauses a portion of the tether engaging at least a portion of thereplacement valve to allow the replacement valve to controllably expand,and further winding of the tether onto the spool reverses movement ofthe tether and retracts the tether toward the handle, and whereinrotation of the second knob in the single direction causes proximalmovement of the locking shaft relative to the inner retention shaft torelease the free end of the tether from the tether retention memberafter the replacement valve is allowed to controllably expand, a thirdknob configured to rotate to cause translation of the nose cone shaftdistally relative to the inner retention shaft to uncover the innerretention member and the first end of the replacement valve, a sleighlocated within the housing and operably connected to proximal ends ofthe nose cone shaft, the inner retention shaft, and the locking shaft,wherein the sleigh is configured to translate from a distal position toa proximal position to move the nose cone shaft, the inner retentionshaft and the locking shaft together, wherein the relative position ofthe nose cone shaft, the inner retention shaft, and the locking shaftare at the same position relative to one another when the sleigh is inthe proximal position and the distal position, a single flush portextending through the housing and in fluid communication with thelocking shaft and the inner retention shaft, and at least one indicatorlocated on the housing, wherein the at least one indication isconfigured to provide auditory and/or visual cues regarding the positionof the tether.

Embodiment 23: A delivery system for controlled deployment of areplacement valve, such as a replacement mitral valve, the deliverysystem comprising an elongate hollow member shaft having an elongatehollow member shaft lumen, a nose cone shaft extending through theelongate hollow member shaft lumen, a nose cone located on a distal endof the nose cone shaft, the nose cone having the nose cone shaft lumenextending therethrough, an inflation lumen, and a balloon located atleast partially on an external surface of the nose cone, the balloonbeing in fluid communication with the inflation lumen and configured toexpand and deflate, wherein the nose cone and the elongate hollow membershaft are configured to releasably retain the replacement valve.

Embodiment 24: The delivery system of Embodiment 23, further comprisingan inflation source to inflate the balloon.

Embodiment 25: The delivery system of any one of Embodiments 23-24,wherein the elongate hollow member shaft is configured to at leastpartially cover the balloon in a deflated position.

Embodiment 26: The delivery system of any one of Embodiments 23-25,wherein the balloon extends distal to the nose cone in an inflatedposition.

Embodiment 27: The delivery system of any one of Embodiments 23-26,wherein the balloon does not extend distal to the nose cone in aninflated position.

Embodiment 28: The delivery system of any one of Embodiments 23-27,wherein the balloon forms a generally toroidal shape in an inflatedposition.

Embodiment 29: The delivery system of any one of Embodiments 23-28,wherein in a deflated position, the balloon is located on a taperedportion of the nose cone.

Embodiment 30: A method for the controlled deployment of a replacementvalve, the method comprising inserting a distal end of a delivery systemthrough an aperture in a heart into a left ventricle of the heart,inflating a balloon located on a nose cone of the delivery system,translating the delivery system distally to pass the expanded balloonthrough a mitral annulus and into a left atrium of the heart, andreleasing a replacement valve from the delivery system into the mitralannulus.

Embodiment 31: The method of Embodiment 30, where a guidewire is notused.

Embodiment 32: The method of any one of Embodiments 30-31, where aseparate balloon catheter is not used.

The method of any one of Embodiments 30-32, further comprisingadditionally inflating the balloon when located in the left atrium.

The method of any one of Embodiments 30-33, further comprising deflatingthe balloon and withdrawing the delivery system from the heart.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a delivery device for a valve.

FIG. 2 illustrates a distal end of an embodiment of the delivery device.

FIG. 3 illustrates a cross section of an embodiment of the deliverydevice.

FIG. 4 illustrates a distal end of an embodiment of the delivery deviceof FIGS. 1-3 with the nosecone removed.

FIG. 5 illustrates an embodiment of a replacement valve.

FIG. 6 illustrates a cross section of an embodiment of the deliverydevice including the replacement valve of FIG. 5.

FIGS. 7-11 illustrate an embodiment of an implantation procedure of areplacement valve using the delivery device.

FIG. 12 illustrates the handle of a delivery device with a portion ofthe housing removed.

FIG. 13 illustrates the handle of the delivery device with a portion ofthe housing and a portion of the sleigh removed.

FIG. 14 illustrates a cross section of the handle of the deliverydevice.

FIG. 15 illustrates translation of the unlocked sleigh in the handle.

FIG. 16 illustrates a transapical approach for a delivery device.

FIG. 17 illustrates a replacement heart valve implanted at the nativemitral valve of a heart.

FIGS. 18-21 illustrate an inflatable nosecone balloon on a deliverysystem and a method of establishing a guidewire pathway without the useof an inflatable nosecone balloon.

DETAILED DESCRIPTION

The present specification and drawings provide aspects and features ofthe disclosure in the context of several embodiments of replacementheart valves, delivery devices and methods that are configured for usein the vasculature of a patient, such as for replacement of naturalheart valves in a patient. These embodiments may be discussed inconnection with replacing specific valves such as the patient's aorticor mitral valve. However, it is to be understood that the features andconcepts discussed herein can be applied to products other than heartvalve implants. For example, the controlled positioning, deployment, andsecuring features described herein can be applied to medical implants,for example other types of expandable prostheses, for use elsewhere inthe body, such as within an artery, a vein, or other body cavities orlocations. In addition, particular features of a valve, delivery device,etc. should not be taken as limiting, and features of any one embodimentdiscussed herein can be combined with features of other embodiments asdesired and when appropriate. While certain of the embodiments describedherein are described in connection with a transapical delivery approach,it should be understood that these embodiments can be used for otherdelivery approaches. Moreover, it should be understood that certain ofthe features described in connection with some embodiments can beincorporated with other embodiments, including those which are describedin connection with different delivery approaches.

FIG. 1 illustrates an embodiment of a delivery device or system 100. Thedelivery system 100 can be used to deploy a prosthesis/implant, such asa replacement heart valve as described elsewhere in this specification,within the body. The delivery system 100 can receive and/or coverportions of the prosthesis such as a first end and second end of theimplant. For example, the delivery system 100 may be used to deliver anexpandable implant such as replacement mitral valve prosthesis 30illustrated in FIG. 5, wherein the second end 14 is configured to bedeployed or expanded before the first end 12. Replacement heart valvescan be delivered to a patient's heart mitral valve annulus or otherheart valve location in various ways, such as by open surgery,minimally-invasive surgery, and percutaneous or transcatheter deliverythrough the patient's vasculature. The delivery system 100 illustratedin FIG. 1 can be relatively short to more easily be used in an openheart procedure or other more direct procedures than the percutaneousprocedure starting at the leg. At the same time, the delivery system 100can still be relatively flexible to allow, for example, advancementthrough the pulmonary veins or the wall of the left atrium and thenbending of the delivery device for proper placement at the mitral valve.In some embodiments, the delivery system 100 is particularly suitablefor delivering a replacement heart valve to a mitral valve locationthrough a transapical approach (e.g., through the apex of the heart).

With reference first to the embodiment illustrated in FIG. 1, thedelivery system 100 can include a handle 110 and a plurality of sheathsand/or shafts such as the illustrated outer elongate hollow member shaft114. As will be described in further detail below, the plurality ofshafts can be sized and shaped to be slidable relative to each other.Accordingly, it should be understood that one or more of the pluralityof shafts can be concentric with respect to another of the shafts tofacilitate slidable movement of the shafts relative to each other. Theplurality of shafts can be coupled to one or more other components ofthe delivery system 100. In some embodiments, the handle 110 can includea plurality of switches, levers, or other actuatable mechanisms whichcan be used to control the movement of the one or more shafts of thedelivery system 100 and/or to control the operation of other componentsof the delivery system 100. A discussion of the handle 110 can be foundbelow.

With continued reference to the embodiment of FIG. 1, the deliverysystem 100 can include an outer elongate hollow member such as the outerelongate hollow member shaft 114 having a proximal and distal end. Asused to describe the components of the delivery system, “proximal”refers to a location of the component that is closer to the handle 110,and “distal” refers to a location of the component that is further fromthe handle 110. In some embodiments, the proximal end of the outerelongate hollow member shaft 114 can be coupled to the handle 110. Insome embodiments, the outer elongate hollow member shaft 114 can befixed relative to the handle 110. In some embodiments, the outerelongate hollow member shaft 114 can be movable relative to the handle110. The outer elongate hollow member shaft 114 can include sheathand/or capsule, and may be made of one or multiple members. The outerelongate hollow member shaft 114 can have the same diameter from theproximal to distal end, or the diameter may vary. The outer elongatehollow member shaft 114 can be formed from a variety of materials,including ePTFE and PEEK, as well as other biocompatible materials.Further, the outer elongate hollow member shaft 114 can include acoating, such as a hydrophilic coating.

In some embodiments, the outer elongate hollow member shaft 114 cancover at least a portion of a collapsed or compressed implant 30 whilethe implant 30 is being delivered to the deployment site. For example,the outer elongate hollow member shaft 114 can cover at least the secondend 14 of the implant 30 while the first end 12 of the implant 30 isreceived within a hollow nose cone 118, described further below. In someembodiments, the outer elongate hollow member shaft 114 can also coverthe first end 12 of the implant 30. The outer elongate hollow membershaft 114 can be sized and shaped such that the outer elongate hollowmember shaft 114 can retain the implant 30 in a compressed state as itis delivered to the deployment site. Accordingly, the outer elongatehollow member shaft 114 can function as a capsule for receiving theimplant 30. As shown in the illustrated embodiment, the outer elongatehollow member shaft 114 can have a constant or substantially constantouter diameter throughout the entirety, or a substantial portion of theentirety, of its length. The outer elongate hollow member shaft 114 canbe moveable relative to the nose cone 118 to uncover the second end 14of the implant 30 while the first end 12 of the implant 30 remainsengaged to an inner retention member (described below) within the nosecone 118 and remains covered by the nose cone 118.

FIG. 5 shows an example of the implant 30 that can be inserted into thedelivery system 100. The implant 30 can take any number of differentforms. A particular example of frame for an implant 30 is shown herein,though it will be understood that other designs can also be used. Theimplant 30 can include one or more sets of anchors, such as ventricularanchors 80 extending proximally when the implant frame is in an expandedconfiguration and atrial anchors 82 extending distally when the implantframe is in an expanded configuration. The implant 30 can also includestruts 72 having mushroom-shaped tabs 74 on the ends at the first side12. Further, the implant 30 can be at least partially surrounded by anannular flap 81 between the ventricular anchors 82 and the atrialanchors 82 near the second side 14. This flap 81 can wrap around theframe of the implant 30 and help position the implant 30 in the desiredposition in the body.

Additional details and example designs for an implant are described inU.S. Pat. Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. PatentPublication Nos. 2011/0313515, 2012/0215303, 2014/0277390, 2014/0277422,2014/0277427, the entirety of these patents and publications are herebyincorporated by reference and made a part of this specification. Furtherdetails and embodiments of a replacement heart valve or prosthesis andits method of implantation are also described in U.S. patent applicationSer. No. 14/716,507, filed May 19, 2015, and Ser. No. 15/141,684, filedApr. 28, 2016, the entirety of each of which is hereby incorporated byreference and made a part of this specification.

The outer elongate hollow member shaft 114 can include a marker 117positioned proximate the distal end, such as a radiopaque marker thatallows for visualization by a physician. In some embodiments, the outerelongate hollow member shaft 114 can be formed of multiple layers ofmaterial, such that the outer elongate hollow member shaft 114 includesat least a first radial portion and a second radial portion. This canadvantageously allow for the use of two types of material for the outerelongate hollow member shaft 114. For example, at least a portion of thefirst portion can be positioned radially outward from the second portionrelative to a central longitudinal axis of the outer elongate hollowmember shaft 114. The first portion, which may be considered an outerlayer, can be formed from a relatively rigid material, such as PEBAX,ULTEM, PEAK and any other biocompatible material as desired. This canadvantageously provide some degree of rigidity for the outer portion ofthe elongate hollow member shaft 114. The second portion, which may beconsidered an inner layer, can be formed from a more compliant material,such as PTFE, ePTFE and any other biocompatible material as desired.This can advantageously provide a more compliant inner surface for theouter elongate hollow member shaft 114, which can be beneficial whencontacting other components of the delivery system 100 and theprosthesis. In some embodiments, the second portion can be a liner whichis applied to the first portion.

While the outer elongate hollow member shaft 114 can be formed withmultiple portions formed from multiple materials, it is alsocontemplated that the outer elongate hollow member shaft 114 can be aformed from a single material.

With reference now to FIGS. 2-4 (where FIGS. 2 and 4 illustrate deliverysystem 100 without the outer elongate hollow member shaft 114 beingshown), the delivery system 100 can include, from radially inside toradially outside, a nose cone shaft 130, an inner retention shaft 124provided concentrically over the nose cone shaft 130, and a lockingshaft 122 provided concentrically over the inner retention shaft 124.Each of the shafts can move axially with relation to one another, and insome embodiments, some of these shafts may be moved together. In FIGS. 2and 4, it will be noted that the locking shaft 122 has been withdrawnproximally for convenience of viewing portions of the inner retentionshaft 124, while in FIG. 3, the locking shaft 122 is illustrated asbeing advanced more distally along the inner retention shaft 124. FIG. 4as illustrated has the nose cone 118 removed.

The nose cone shaft 130 has a proximal end operably connected to thehandle 110 and a distal end coupled to nose cone 118. The nose coneshaft 130 may be hollow along its length to receive a guidewire. Nosecone 118 comprises an elongate, hollow portion 119 with a proximallyfacing opening 121, and a tapered distal portion 123 (as shown in FIG.3). The nose cone shaft 130 may be coupled to the nose cone 118 at adistal end of the elongate, hollow portion 119, such that the nose coneshaft 130 extends through the proximal opening 121 and ends at theintersection 125 between the elongate, hollow portion 119 and thetapered distal portion 123 at nose cone lock 129. The nose cone 118 canfurther contain a lumen 127 extending from the distal end of the nosecone shaft 130 to the distal end of the nose cone 118, which can allow aguide wire to pass through. The nose cone 118 can be formed from arelatively rigid, high durometer material. The nose cone 118, includingboth the elongate, hollow portion and the tapered, distal portion, canhave a length, measured from the distalmost end to a proximalmost end,of between approximately 5 mm to 50 mm, between approximately 10 mm toapproximately 40 mm, between approximately 15 mm to approximately 25 mm,approximately 20 mm, any other lengths within these ranges, and anyother lengths as desired.

As shown in FIGS. 2 and 3, the tapered distal portion can have a concaveouter surface thereby forming a more defined distal tip of the nose cone118. As shown more clearly in the cross-section of FIG. 3, the nose cone118 can include an outer portion 219 and a nose cone insert 220, thenose cone insert 220 being generally tubular in shape and forming acavity within the nose cone 118 and the outer portion 219 forming thegeneral shape of the nose cone 118 and extending from the proximal tothe distal portion of the nose cone 118. The nose cone insert 220 mayonly be located in the proximal portion of the nose cone 118. This canadvantageously allow for the use of two types of material for the nosecone 118. For example, as shown in the illustrated embodiment, at leasta portion of the outer portion 219 can be positioned radially outwardfrom the nose cone insert 220 relative to a central longitudinal axis ofthe nose cone 118. The outer portion 219 can be formed from a lowerdurometer material such as urethane, PEBAX, polysilicone and any otherbiocompatible material as desired. The nose cone insert 220 can beformed from higher durometer materials such as stainless steels,titanium, and any other biocompatible material as desired. This canadvantageously provide additional structural support for the nose cone118. The nose cone insert 220 can have an inner diameter of about 0.2,0.25, 0.3, 0.343, 0.35, or 0.4 inches and a length of about 0.6, 0.65,0.7, 0.709, 0.75, or 0.8 inches. The nose cone insert 220 can have aninner diameter of greater than about 0.2, 0.25, 0.3, 0.343, 0.35, or 0.4inches and a length of greater than about 0.6, 0.65, 0.7, 0.709, 0.75,or 0.8 inches. The nose cone insert 220 can have an inner diameter ofless than about 0.2, 0.25, 0.3, 0.343, 0.35, or 0.4 inches and a lengthof less than about 0.6, 0.65, 0.7, 0.709, 0.75, or 0.8 inches. In someembodiments, the nose cone insert 220 can include threading forattachment to a shaft, such as nose cone shaft 130. The threading can belocated towards the distal end of the nose cone 118, and can be aseparate piece such as nose cone lock 129. In some embodiments, theouter portion 219 can be overmolded onto the nose cone insert 220 and/orattached using mechanical fasteners such as screws, bolts, rivets, andthreaded couplings, chemical fasteners, such as adhesives, or othertypes of fastening techniques such as welding. In some embodiments, thenose cone 118 can be a single unit formed from a single material.Further, the nose cone 118 can be flexible and self-dilating.

With reference particularly to the cross-sectional view of FIG. 3, theoutermost diameter of the nose cone 118, such as the outer diameter ofthe elongate, hollow portion 119, can be similar to, or equal to, theouter diameter of an outer shaft and/or outer component, such as theouter elongate hollow member shaft 114. As shown in the illustratedembodiment, the elongate, hollow portion 119 has an outer diameter whichis similar to that of the outer elongate hollow member shaft 114. Thiscan form a generally smooth transition in diameter between the nose cone118 and the outer shaft and/or the outer component if and when the nosecone 118 is brought into contact with the outer shaft and/or the outercomponent. In some embodiments, the elongate, hollow portion 119 of thenose cone 118 can have an outer diameter of approximately 31 Fr or 32 Frand the outer shaft and/or outer component can have an outer diameter ofapproximately 31 Fr or 32 Fr.

In some embodiments, the outer diameter of the nose cone 118, such asthe elongate, hollow portion 119, can be similar to, or equal to, theinner diameter of the outer elongate hollow member shaft 114 such thatnose cone 118 can be partially received within the outer elongate hollowmember shaft 114. In some embodiments, the elongate, hollow portion ofthe nose cone 118 can have an outer diameter of approximately 30 Fr andthe outer shaft and/or outer component can have an inner diameter ofapproximately 30 Fr. In some embodiments, the outer shaft can be anoutermost shaft of the delivery system.

With continued reference to the embodiment of FIGS. 2-4, the innerretention shaft 124 is slidable over the nose cone shaft 130, such thatthe nose cone shaft 130 can be moved within the inner retention shaft124 and the inner retention shaft 124 can be moved over the nose coneshaft 130. The distal end of the inner retention shaft 124 can becoupled to at least a portion of an inner retention member 132 that canbe positioned within and be removed from the proximally-facing openingof the nose cone 118. The inner retention member 132 can be attached tothe inner retention shaft 124 with threading 135 (shown in FIG. 3).Further, the inner retention member 132 can have an elongated andproximally tapered design. The inner retention member 132 can be formedof a single material, or a plurality of different materials.

Further, as shown in FIG. 2, the inner retention member 132 can have aproximal end 234 and a distal end 236 with a plurality of slots 238sized and shaped to receive portions of a first end 12 of the implant 30positioned proximate the proximal end 234. For example, the innerretention member 132 may comprise a ring surrounding the inner retentionshaft 124 with slots 238 configured to receive longitudinally-extendingstruts 72 on the implant 30 that are located just distal to enlarged,mushroom-shaped locking tabs 74 (shown in FIG. 5). Slots 238 can becircumferentially-spaced from each other extend along a longitudinalaxis of the inner retention member 232. In some embodiments, the innerretention member 132 can include a cavity 239 positioned distal theslots 238. The cavity 239 can be sized and shaped to receive portions ofthe first end 12 of the implant 30, such as the locking tabs 74. Asshown in the illustrated embodiment, the cavity 239 can have an annularshape or may be considered to extend circumferentially around the innerretention member 132. In some embodiments, the inner retention member132 can include a taper towards the proximal end 234. This canfacilitate removal of the inner retention member 132 from the heart byreducing the diameter at the proximalmost end of the inner retentionmember 132 and reducing the likelihood of snagging on tissue.

The inner retention shaft 124 can cooperate with the inner retentionmember 132 and the nose cone 118 to release a first end of theprosthesis from the nose cone 118. As shown in FIG. 6, the first end 12of the implant 30 can be placed in a compressed state such that thefirst end 12 of the implant 30 is retained between the inner retentionmember 132 and the nose cone 118 when the inner retention member 132 isreceived within and covered by the nose cone 118. Proximal movement ofthe inner retention shaft 124 with respect to the nose cone 118 canresult in proximal movement of the inner retention member 132 relativeto the nose cone 118 which can release the first end 12 of theprosthesis 30 from the nose cone 118. Similarly, distal movement of thenose cone 118 relative to the inner retention shaft 124, and thus theinner retention member 132, can also release the first end 12 of theprosthesis 30 from the nose cone 118. If the implant 30 is not coveredby the outer elongate hollow member shaft 114, once the inner retentionshaft 124 is moved relative to the nose cone 118 to uncover the firstend 12 of the implant 30, the first end 12 of the implant 30 mayself-expand from its compressed state to an expanded configuration.

Further, the inner retention member 132 can include a circumferentialcavity proximate the distal end 236. The cavity can be formed betweenone or more radially extending protrusions, such as ridges 244, 246,illustrated in FIG. 3. As shown in the illustrated embodiment of FIGS. 2and 3, the cavity can have an annular shape. A compressible member 242,such as an O-ring, can be received at least partially within the cavity240 as shown in FIG. 3. The compressible member 242 can act as a sealbetween the inner retention member 132 and the nose cone 118 to keep thecomponents together during retraction and allow for smooth sheathinginto the outer elongate hollow member shaft 114. Moreover, thecompressible member 242 can ensure that there is no gap between the nosecone 118 and the inner retention member 132 to prevent a portion of theimplant 30 from being caught during removal of the nose cone 118 andinner retention member 132. Further, the compressible member 242 cankeep the nose cone 118 from coming into contact with the inner retentionmember 132.

Further, the inner retention shaft 124 can include a tether retentionmember 134 proximal to the inner retention member 132. As shown in theillustrated embodiment of FIG. 4, the tether retention member 134 can bea C-lock mounted on the inner retention shaft 124 having a longitudinalopening or slot 131 through which a tether or lasso 136, such as anitinol wire having a suture crimped on the end, can pass. In order toretain the tether 136 within the tether retention member 134, the end138 of the tether 136 can be sized and shaped such that the end 138 isprevented from passing distally through the opening of the tetherretention member 134 when the end 138 is located proximal to theopening. For example, the end 138 of the tether 136 can be knotted suchthat at least one dimension of the end 138 prevents the end 138 frompassing distally through the opening. The locking shaft 122, describedbelow, will further restrain the tether 136 from moving radiallyoutwards through the slot in the tether retention member 134 and thusthe locking shaft 122 and tether retention member 134 cooperate toreleasably engage the tether 136.

In the illustrated embodiment, provided over the inner retention shaft124 is a locking shaft 122. In some embodiments, inner retention shaft124 can be sized and shaped such that inner retention shaft 124 isslidable within the locking shaft 122. For example, in some embodiments,the inner retention shaft 124 can be moved within the locking shaft 122.In some embodiments, the locking shaft 122 can be moved over the innerretention shaft 124. As shown in FIGS. 2 and 3, the locking shaft 122may slide over the inner retention shaft 124 and cover the tetherretention member 134. The locking shaft 122 can cooperate with thetether retention member 134 to retain a tether, or lasso, 136 (shown inFIG. 4) attached to an implant 30 until the locking shaft 122 istranslated proximally to release the tether 136. Moreover, locking shaft122 can be sized and shaped such that the outer elongate hollow membershaft 114 is slidable over the locking shaft 122.

When the tether 136 is positioned in the tether retention member 134,the tether 136 can be released by translating the locking shaft 122proximally. Thus, a radially outwards tension force will pull the end138 of the tether 136 out of the tether retention member 134. The tether136 can be tensioned and angled such that the tether 136 would pass overthe tether retention member 134 when tether retention member 134 isuncovered from the locking shaft 122. It should be understood that othermechanisms can be used for tether retention assembly in lieu of the lockand tether retention member 134 including, but not limited to, clampswhich engage the tether 136. As shown in FIG. 6, the tether 136 canengage at least a portion of the prosthesis, such as the second end 14of the implant 30. For example, in some embodiments, the tether 136 canextend distally from the tether retention member 134, wrap around atleast some portion of the implant 30 when the implant is compressedwithin outer elongate hollow member shaft 114 and nose cone 118, andextend at least proximally through the outer elongate hollow membershaft 114. The end opposite end 138 can be attached to a component ofthe delivery system 100 such that the tether 136 can be retracted intothe delivery system 100 upon release of the tether 136 from the tetherretention assembly 128.

In some embodiments such as that illustrated in FIG. 3, the lockingshaft 122 can include a centering ring/radial protrusion 224, such as anannular and/or tapered disc, positioned proximal to its distal end. Thecentering ring 224 can assist in maintaining the locking shaft 122 in adesired radial alignment relative to the shaft within which the lockingshaft 122 is positioned (e.g., the outer elongate hollow member shaft114). For example, as shown in the illustrated embodiment, the centeringring 224 can assist in maintaining concentricity between the lockingshaft 122 and another shaft such as the outer elongate hollow membershaft 114. The centering ring 224 can be tapered on its proximal end, asshown, for ease of the centering ring 224 entering the outer elongatehollow member shaft 114 during retrieval of the system 10. In someembodiments, the centering ring 224 can include a plurality ofapertures/guide members 226 positioned circumferentially around thelocking shaft 122 and circumferentially spaced from one another for thetether, wire or suture 136 to pass through. Any one of the guide members226 can be used for the tether 136 as is convenient for a user. As shownin the illustrated embodiment, each guide member 226 can be formed as ahole or aperture on the centering ring 224.

The embodiments of FIGS. 6-12 illustrates steps of a method of operatingthe delivery system 100 and releasing an intralumenal frame assembly,such as implant 30, to intralumenal tissue at an in situ targetlocation. The steps of this method can be carried out while the implantis in a radially compacted state within the outer elongate hollow membershaft 114. In some embodiments, the longitudinal axis of the implant 30,which runs between the first 12 and second ends 14 of the implant 30,can be parallel to and/or concentric with the longitudinal axis of oneor more shafts of the delivery system 100. The steps of this method canbe used to transapically deliver a replacement heart valve to a mitralvalve location.

FIG. 6 shows a cross section of the delivery system 100 with the implant30 located in the delivery position. For ease of illustration, theimplant 30 is shown in FIG. 6 with only its metal frame illustrated. Asshown, the outer elongate hollow member shaft 114 covers the implant 30,thus preventing expansion of the implant 30, in particular the secondend 14. Further, the ventricular anchors 80 of the implant extendproximally toward the handle 110, with the outer elongate hollow membershaft 114 radially restraining the ventricular anchors 80 pointingproximally. The outer elongate hollow member shaft 114 extends distallyto the nose cone 118, which covers the inner retention member 134. Thefirst end 12 of the implant 30 is positioned within the inner retentionmember 134, with struts 72 located within the slots of the innerretention member 134 and covered by the nose cone 118. Further, thetether 136 extends distally from the handle 110, within the outerelongate hollow member shaft 114, through one of the guide members 226,and is wrapped around the implant, more preferably wrapping around theventricular anchors 80 that extend proximally. The tether 136 thenextends proximally to the tether retention member 134 located within thelocking shaft 122, where the end of the tether 136 is locked in positionas described above.

With reference next to the step of FIG. 7, once the delivery system 100has positioned the implant at the in situ target location, the outerelongate hollow member shaft 114 can be moved relatively away from thenose cone 118, either by proximally retracting the outer elongate hollowmember shaft 114 and/or distally advancing the nose cone 118, nose coneshaft 130, inner retention shaft 124, and inner retention member 132, touncover at least a portion of the implant 30, in particular the secondend 14 of the implant 30. As shown in FIG. 7, there may be a slightbulge in the implant 30 during this phase.

With reference next to the step of FIG. 8, the outer elongate hollowmember shaft 114 can be further moved relatively away from the nose cone118 to further uncover the implant 30. As shown in the illustratedembodiment, the second end of the implant 30 has been uncovered with thetether 136 being the only component restraining the radial dimension ofthe frame of the implant 30. By maintaining tension on the tether 136,the tether 136 can continue to at least partially restrain the radialdimension of the second end and can advantageously reduce the speed atwhich the second end radially expands. The tether 136 can becontinuously released by the user at the handle 110 until the second end14 of the implant 30 is fully expanded. In some embodiments, the tether136 can be configured such that the first end 12 remains in the fullycompacted state when the second end 14 is fully uncovered.

It should be noted that the first end 12 of the implant 30 can remaincovered by the nose cone 118 during this step such that the first end 12remains in a radially compacted state. Moreover, as shown in theillustrated embodiment, the second end 14 of the implant 30 has at leastpartially expanded in the radial dimension with the ventricular anchors80 having been flipped to extend distally away from the second end ofthe implant 30 (and distally away from the handle 110). By controllingthe expansion of the second end 14 of the implant 30 with the tether136, the user can minimize the risk of the ventricular anchors 80catching on surrounding tissue when the ventricular anchors 80 flip fromextending proximally to extending distally.

As shown in FIG. 9, once the second end 14 of the implant 30 is fullyexpanded, the locking shaft 122 can be moved relatively proximally toexpose the tether retention member 134, thus allowing the tether 136 tofully release from the tether retention member 134.

Next, as shown in FIG. 10, the tether retention member 134 has releasedthe end 138 of the tether 136. It should be noted that the first end ofthe implant 30 can remain covered by the nose cone 118 during this stepsuch that the first end remains in a radially compacted state. Asdiscussed below, the tether 136 and end 138 can be retracted proximallyinto the delivery system 100 at this point.

With reference next to the step of FIG. 11, the inner retention member132 can be moved relatively away from the nose cone 118 such that thefirst end of the implant 30 can radially expand to its fully expandedconfiguration. This can be achieved by either distally moving the nosecone 118 relative to the inner retention member 132 and/or moving theinner retention member 132 proximally relative to the nose cone 118.After expansion and release of the implant 30, the inner retentionmember 132 and the nose cone 118 can be withdrawn through the center ofthe implant 30 and into the outer elongate hollow member shaft 114.Advantageously, as shown and discussed above, the inner retention member132 can be tapered on the proximal end in order to more easily slideinto the outer elongate hollow member shaft 114. Prior to withdrawing,the nose cone shaft 130 can be translated proximally to abut again thedistal end of the inner retention member 132, which provides a taperedsurface for the nose cone 118 to enter the outer elongate hollow membershaft 114 as well. In some embodiments, the locking shaft 122, the innerretention shaft 124 and the nose cone shaft 130 are moved proximallytogether so that the inner retention member 132 enters the outerelongate hollow member shaft 114 and the nose cone 118 abuts the distalend of the outer elongate hollow member shaft 114, and then the deliverysystem 100 is removed from the patient

The delivery device 100 may be provided to users with an implant 30preinstalled, such as illustrated in FIG. 6. In other embodiments, theimplant 30 can be loaded onto the delivery device 100 shortly beforeuse, such as by a physician or nurse.

Handle

FIGS. 12-15 show embodiments of a handle 110 that can be used inconjunction with the delivery device 100 as discussed in detail above.

FIG. 12 shows an internal viewpoint of the handle 110 with half of thehousing 500 (shown in FIG. 1) removed. As shown, the handle 110 caninclude an outer elongate hollow member shaft knob 501 for translatingthe outer elongate hollow member shaft 114 as discussed above.

Moving proximally, the housing 500 can contain a tether (or lasso) knob502. The lasso knob 502 can be rotated in order to controllably expandthe implant 30, to release the tether 136 from the implant 30, and toretract the tether 136 towards the handle 110, as discussed above.Advantageously, the implant 30 can be completely released from thetether 136 and the tether 136 can be retracted towards the handle 110through rotation of the tether knob 502 in a single direction, thuseliminating confusion or mistakes from a user and simplifying theoverall design of the handle 110.

As discussed above, in the undeployed position the tether 136 can beheld tightly around the implant 30 so as to prevent expansion of theimplant 30. Once the implant 30 is located in the proper position, thetether 136 can be loosened from the implant 30 by a user turning thetether knob 502. The tether 136 can be loosened through motion of thetether knob 502 which unspools tether 136 from a spool, which may beprovided as a cavity in the tether knob 502 or elsewhere in the handle110. Upon initial turning of the tether knob 502 by a user, more of thetether 136 can be released from the spool towards the distal end wherethe implant 30 is located. As the implant 30 is configured toself-expand radially outwards, the release of more tether 136 can allowthe implant to controllably radially expand. A user can continue to turnthe tether knob 502 to release more tether, thus allowing full expansionof the implant 30.

Further, as the tether knob 502 is rotated, the tether knob 502 pushes atether engager 503 proximally (shown in FIG. 13 which includes part of asleigh 512, discussed below, removed for clarity). The tether engager503 can include a screw like component that mates with an internalsurface of the tether knob 502. Thus, as the tether knob 502 rotates,the tether engager 503 will be translated in a linear direction. In someembodiments, the tether engager 503 is located in a distal position whenthe tether 136 is wrapped around the implant 30, and translatesproximally.

As the tether engager 503 moves proximally, it can abut a tether block509 which can occur once the implant 30 is fully expanded. Uponcontinued turning of the tether knob 502, the tether engager 503 willpush the tether block 509 proximally. The tether block 509 is attachedto or operably connected to the proximal end of the locking shaft 122,so that the locking shaft 122 will move proximally as the tether engager503 is moved proximally. This proximal movement will expose the tetherretention member 134 on the inner retention shaft 124. Thus, at thispoint, the tether 136 can release from the tether retention member 134.The tether 136 and tether engager 503 can move at different distancesupon turning of the tether knob 502. For example, one turn of the tetherknob 502 can translate the tether engager 503 about 1 inch while thetether 136 will move about 3.14 inches. Further, the tether engager 503can de-couple from the tether knob 502 after a certain amount of turn(e.g., after the tether 136 is released) and thus the tether knob 502can rotate freely without moving the tether engager 503 to retract thetether 136.

Advantageously, once the tether 136 is free of the tether retentionmember 134, it has been unspooled via the tether knob 502. Then, a usercan continue to turn the tether knob 502 in the same direction as beforeto retract the tether 136 towards the handle 110, creating a parabolicmotion of the tether 136 from release to retraction. Specifically, thetether knob 502 is turned in a single direction to release the spooledtether from the tether knob 502. Then, once the tether 136 is completelyunspooled, continued motion of the tether knob 502 re-spools the tether136 back into the cavity in the tether knob 502 or handle 110. Thus, thetether knob 502 can be turned in one direction to both release andretract the tether 136. The tether can be drawn through tether channels504 in the handle 110 distal to the tether knob 502 and wrapped into acircumferential spool in the tether knob 502 to safely store away thetether. As mentioned above, the tether 136 can include a nitinol wirewith a suture crimped on the distal end of the nitinol wire. Thisattachment can occur proximal to the centering ring 224 within the outerelongate hollow member shaft 114. Further, the tether 136 can include acrimp sleeve stop located on the nitinol wire portion of the tether 136,relatively near the attachment of the nitinol wire and the suture (forexample approximately 1 inch away). The crimp sleeve stop can preventfull retraction of the tether 136 into the handle 110 by abuttingagainst the handle 114, or components near the distal end of the handle114, thus providing for a mechanical stop.

Moving to the proximal end of the handle 110, a nose cone knob 506 isshown which is configured to advance or retract the nose cone 118 uponturning by a user, discussed above. As the nose cone knob 506 is turned,a lead screw coupled to the nose cone knob 506 and nose cone shaft 130can be translated to provide proximal and distal motion to the nose coneshaft 130.

In addition, as shown in FIGS. 12-13, the handle 110 can include asleigh 512 located within the housing 500. Specifically, the sleigh(e.g., cradle or sled) 512 has a generally tubular shape that isreceived within the proximal end of the generally tubular housing 500.The outer diameter of the sleigh 512 can be less than the outer diameterof the housing 500. Further, the sleigh 512 has a hollow interior inwhich the proximal ends of the inner retention shaft 124, locking shaft122, and the nose cone shaft 130 are attached to, whether directly orthrough an intermediate component.

The sleigh 512 is configured to move proximally within the housing 500and distally back into the housing 500. Thus, by pulling the sleigh 512proximally relative to the housing 500 to a proximal position shown inFIG. 16, the inner retention shaft 124, locking shaft 122, and nose coneshaft 130, and thus the nose cone 118 and inner retention member 132,can be pulled proximally in one motion. Therefore, these components canbe pulled into the outer elongate hollow member shaft 114, which isattached to the housing 500, for ease of withdrawal from a patient. Thisallows for fewer complications in pulling the different elements throughthe center of the implant 30.

The handle 110 can further include sleigh lock 510 located between thenose cone knob 506 and tether knob 502. The sleigh lock 510 can berotated approximately 180° in order to unlock and lock translationalmotion of the sleigh 512. Thus, when the sleigh lock 510 is activated,the sleigh 512 cannot be pulled proximally. However, upon release of thesleigh lock 510, the sleigh 512 can be pulled proximally. In someembodiments, a user can pull on the deactivated sleigh lock 510 to pullthe sleigh 512 proximally.

Indicators can be used on the outer surface of the handle, such asincorporated into the housing 500, in order to provide a user withvisual or auditory indications of the locations of certain parts of thesystem 100. For example, as shown in FIG. 12, a channel, slot oraperture 520 can pass through the housing 500 of the handle 110 around aproximal end of the tether engager 503. The tether engager 503 canfurther have a projection 522 on or near its proximalmost surface whichcan extend into the channel 520. Thus, as the tether engager 503 movesproximally through the turning of the tether knob 502, a user can seethe location of the tether engager 503 based on the position on theprojection 522. Further, the slot 520 can contain “speed bumps” 521 onan inside surface of the slot 520 that can provide for a click when theprojection 522 passes over them, which can also provide feedback to auser on the actions taken at the distal end of the system 100. Forexample, the speed bumps can indicate when the tether 136 is fullyexpanded and when the tether engager 503 is about to release the tether136 through movement of the locking shaft 122.

Another aspect of the handle 110 is the single flush port 530 exposedoutside the handle, which is shown in the cross-section of FIG. 14. Theflush port 530 is fluidly connected to the inner retention shaft 124 andthe locking shaft 122, thus allowing fluid to flush out both of thoseshafts so a second flush port is not needed. Further, the locking shaft122 can include a plurality of radial apertures (not shown) on itsproximal end outside of the handle. Advantageously, this allows fluid topass from the locking shaft 122 and into the lumen formed by the outerelongate hollow member shaft 114. Thus, flushing through the singleflush port 530 can provide fluid to the inner retention shaft 124,locking shaft 122, and the outer elongate hollow member shaft 114.

Insertion Methodology

FIG. 16 illustrates a transapical approach for use with the deliverydevice 100. As shown, the delivery device 100 can access a mitral valvethrough the apex 7 of the heart. As depicted in FIG. 16, a guidewire 10is advanced into the left ventricle 6 of the heart through a puncture oropening 9 near the apex 7. The heart may be accessed through a limitedthoracotomy, small trocar puncture, or small catheter puncture. With theguidewire 10 in place, the physician can insert the device 100 to theleft ventricle 6 and deploy the heart valve as disclosed above. In someembodiments, a guidewire is not used.

Reference is now made to FIG. 17 which illustrates a schematicrepresentation of an embodiment of a replacement heart valve positionedwithin a native mitral valve of a heart 83. Further details regardinghow the prosthesis 70 may be positioned at the native mitral valve aredescribed in U.S. patent application Ser. No. 14/716,507, filed May 19,2015, the entirety of which is hereby incorporated by reference,including but not limited to FIGS. 13A-15 and paragraphs [0036]-[0045].A portion of the native mitral valve is shown schematically andrepresents typical anatomy, including a left atrium 102 positioned abovethe native mitral valve annulus 106 and a left ventricle 104 positionedbelow the annulus 106. The left atrium 102 and left ventricle 104communicate with one another through the mitral annulus 106. Also shownschematically in FIG. 17 is a native mitral leaflet 108 having chordaetendineae 110 that connect a downstream end of the mitral leaflet 108 tothe papillary muscle of the left ventricle 104. The portion of theimplant 30 disposed upstream of the annulus 106 (toward the left atrium)can be referred to as being positioned supra-annularly. The portiongenerally within the annulus 106 is referred to as positionedintra-annularly. The portion downstream of the annulus 106 is referredto as being positioned sub-annularly (toward the left ventricle).

As illustrated in FIG. 17, the replacement heart valve (e.g., implant30) can be disposed so that the mitral annulus 106 is between theventricular anchors 80 and the atrial anchors 82. In some situations,the implant 30 can be positioned such that ends or tips of theventricular anchors 80 contact the annulus 106. In some situations, theimplant 30 can be positioned such that ends or tips of the ventricularanchors 80 do not contact the annulus 106. In some situations, theimplant 30 can be positioned such that the ventricular anchors 80 do notextend around the leaflet 108.

The implant 30 can be positioned so that the ends or tips of theventricular anchors 80 are on a ventricular side of the mitral annulus106 and the ends or tips of the atrial anchors 82 are on an atrial sideof the mitral annulus 106. The ventricular anchors 80 can be positionedsuch that the ends or tips of the ventricular anchors 80 are on aventricular side of the native leaflets beyond a location where chordaetendineae 110 connect to free ends of the native leaflets. Theventricular anchors 80 may extend between at least some of the chordaetendineae 110 and, in some situations such as those shown in FIG. 17,can contact or engage a ventricular side of the annulus 106. It is alsocontemplated that in some situations, the ventricular anchors 80 may notcontact the annulus 106, though the ventricular anchors 80 may stillcontact the native leaflet 108. In some situations, the ventricularanchors 80 can contact tissue of the left ventricle 104 beyond theannulus 106 and/or a ventricular side of the leaflets.

During delivery, the ventricular anchors 80 (along with the frame) canbe moved toward the ventricular side of the annulus 106 with theventricular anchors 80 extending between at least some of the chordaetendineae 110 to provide tension on the chordae tendineae 110. Thedegree of tension provided on the chordae tendineae 110 can differ. Forexample, little to no tension may be present in the chordae tendineae110 if the leaflet 108 is shorter than or similar in size to theventricular anchors 80. A greater degree of tension may be present inthe chordae tendineae 110 where the leaflet 108 is longer than theventricular anchors 80 and, as such, takes on a compacted form and ispulled toward the native valve annulus. An even greater degree oftension may be present in the chordae tendineae 110 where the leaflets108 are even longer relative to the ventricular anchors 80. The leaflet108 can be sufficiently long such that the ventricular anchors 80 do notcontact the annulus 106.

The atrial anchors 82 can be positioned such that the ends or tips ofthe atrial anchors 82 are adjacent the atrial side of the annulus 106and/or tissue of the left atrium 102 beyond the annulus 106. In somesituations, some or all of the atrial anchors 82 may only occasionallycontact or engage atrial side of the annulus 106 and/or tissue of theleft atrium 102 beyond the annulus 106. For example, the atrial anchors82 may be spaced from the atrial side of the annulus 106 and/or tissueof the left atrium 102 beyond the annulus 106. The atrial anchors 82could provide axial stability for the implant 30. In some situations,some or all of the atrial anchors 82 may not contact an annular flap 81.This may occur when the annular flap 81 is in a collapsed configurationalthough it may also occur when the annular flap 81 is in an expandedconfiguration. In some situations, some or all of the atrial anchors 82may contact the annular flap 81. This may occur when the annular flap 81is in an expanded configuration although it may also occur when theannular flap 81 is in a collapsed configuration. It is also contemplatedthat some or all of the atrial anchors 82 may contact the atrial side ofthe annulus 106 and/or tissue of the left atrium 102 beyond the annulus106

The annular flap 81 can be positioned such that a proximal portion ofthe annular flap 81 is positioned along or adjacent an atrial side ofthe annulus 106. The proximal portion can be positioned between theatrial side of the annulus 106 and the atrial anchors 82. The proximalportion can extend radially outward such that the annular flap 81 ispositioned along or adjacent tissue of the left atrium 102 beyond theannulus 106. The annular flap 81 can create a seal over the atrial sideof the annulus 106 when the flap 81 is in the expanded state. Furtherdiscussion on the annular flap 81 can be found in U.S. application Ser.No. 14/716,507, hereby incorporated by reference in its entirety.

Inflatable Nosecone Balloon

Disclosed herein are embodiments of a delivery system with an inflatablenosecone balloon that can advantageously reduce the time and necessarycomponents for the transapical delivery of a replacement mitral valve.

In some transapical delivery methodologies for the implantation of areplacement mitral valve, generally a three step process may be used.First, a guidewire catheter is threaded through the left ventricle ofthe heart and into the left atrium to place a guidewire. Following, theguidewire catheter is removed and a balloon catheter is threaded ontothe guidewire and a balloon is expanded in the left ventricle. Theballoon is then passed from the left ventricle to the left atrium todetermine whether the balloon passes smoothly between the two anatomicalpositions, indicating that the guide wire is not caught around chordaetendineae or other anatomical structures. The balloon is then removedand the delivery system is inserted along the guidewire.

However, the above-described procedure requires a number of differentdevices (e.g., delivery device, guidewire catheter, and ballooncatheter) and requires the exchanging of different devices. Theseexchanges can lead to unwanted blood loss and can accidently misplacethe guidewire during the removal and replacement of different devices.Further, the exchanging of device leads to a longer overall proceduretime and can be costly with the need to have the plurality of devices.

Accordingly, embodiments of the disclosure are advantageous as theycombine the features of multiple devices previously used into oneeasy-to-use delivery system. By eliminating the device exchange steps,the procedure time can be decreased, the blood loss can be decreased,and the device can be easier to implant.

FIGS. 18-21 show an inflatable balloon 600 that can be incorporatedinto/around the nose cone 118 of a delivery system 100, such asdisclosed in detail above. In some embodiments, the balloon 600 can befolded around the tapered tip of the nose cone 118 of the deliverysystem 100 in a deflated position, such as shown in FIG. 18. The balloon600 can be expanded to form a generally toroidal or donut-shapedstructure surrounding a portion of the nose cone 118 as shown in FIGS.19-21. In some embodiments, the balloon 600 can extend distally past thedistal tip of the nose cone 118. In some embodiments, a distal end ofthe balloon 600 can be approximately the same as the distal end of thenose cone 118. The balloon 600 can be made of rubber, polymer, or othermaterial known for the creation of a balloon 600. In some embodiments,the balloon 600 can be located partially or fully proximal to thetapered tip of the nose cone 118.

The balloon 600 can be adhered chemically or mechanically to the nosecone 118 so that the balloon 600 remains around the nose cone 118 in thedeflated and inflated position. However, in some embodiments the balloon600 may only be attached to a distal end of the nose cone 118 and thusmay extend distal to the distal end of the nose cone 118. In someembodiments, the nose cone 118 may contain grooves or indentations onits outer surface that the balloon 600 can fit into when in thefolded/deflated position. This can provide a smoother transition forbetter apical crossing.

When in the deflated position, as shown in FIG. 18, the balloon 600 canlay along the nose cone 118 to form a generally atraumatic surface,typically in a tapered area of the nose cone 118. The balloon 600 canwrap around an external surface of the nose cone 118. The balloon 600can further attach to a distal tip of the nose cone 118, which allowsthe balloon 600 to be in fluid communication with a lumen in the nosecone shaft 130. Accordingly, the lumen of the nose cone shaft 130 canextend proximally to an inflation source to inflate the balloon 600.

If a smoother profile is desired, a small outer sheath (not shown) maycover the balloon 600. In some embodiments, the outer elongate hollowmember shaft 114 can cover the balloon 600 while in the deflatedposition, either partially or fully. Once the balloon 600 is in the leftventricle 104, as discussed below, this sheath can then be pulledproximally and the balloon 600 can be inflated.

In some embodiments, a separate inflation lumen can be used to inflatethe balloon 600, which can run parallel, or approximately parallel, tothe guide wire lumen in the nose cone shaft 130. In some embodiments,the guidewire lumen can be eliminated and/or replaced with the inflationlumen as no guidewire may be required. By removing the guidewire lumen,the overall dimensions of the delivery system 100 can be reduced. Theinflation lumen can be significantly smaller than the guide wire lumen,and thus the overall distal profile of the delivery system 100 can bereduced.

FIG. 18-21 illustrate steps of an example of a delivery method usingembodiments of the disclosed delivery system 100. As shown in FIG. 18,the distal end of the delivery system 100, including the deflatedballoon 600, can be advanced through a hole in the apex of the heart 83and into the left ventricle 104. The balloon 600 can then be expanded,such as to approximately 5, 10, 15, 20, 25, or 30 mm in diameter, oncein the left ventricle 106 as shown in FIG. 19. However, other balloondimensions can be used as well, and the particular inflation diameter isnot limiting. The delivery system 100 can then be advanced through themitral annulus 106 and towards the left atrium 102 as shown in FIG. 20,which ensures that the delivery system 100 does not gettrapped/entangled within the chorea tendineae 110, mitral valve leaflets108, or other anatomic structures. Once located in the left atrium 100,the implant 30 can be released per the above disclosure while theballoon 600 remains inflated as shown in FIG. 21, though only the frameof the implant 30 is shown. The implant 30 show is discussed in detailin U.S. patent application Ser. No. 15/141,684, filed Apr. 28, 2016, butother implants discussed herein can be used as well. The balloon 600 canbe advanced atrially so it does not occlude any blood flow through themitral valve. If no guidewire is being used, once the balloon 600 isadvanced past the native mitral annulus 106, the balloon 600 can be leftinflated (or partially inflated) which will hold the distal end of thedelivery system 100 in the left atrium 102. In some embodiments, theballoon 600 can be further inflated in the left atrium 102. Once theimplant 30 is positioned, the balloon 600 can be deflated and thedelivery system 100 can be withdrawn from the heart 83.

From the foregoing description, it will be appreciated that an inventiveproduct and approaches for implant delivery systems are disclosed. Whileseveral components, techniques and aspects have been described with acertain degree of particularity, it is manifest that many changes can bemade in the specific designs, constructions and methodology herein abovedescribed without departing from the spirit and scope of thisdisclosure.

Certain features that are described in this disclosure in the context ofseparate implementations can also be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation can also be implemented inmultiple implementations separately or in any suitable subcombination.Moreover, although features may be described above as acting in certaincombinations, one or more features from a claimed combination can, insome cases, be excised from the combination, and the combination may beclaimed as any subcombination or variation of any subcombination.

Moreover, while methods may be depicted in the drawings or described inthe specification in a particular order, such methods need not beperformed in the particular order shown or in sequential order, and thatall methods need not be performed, to achieve desirable results. Othermethods that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionalmethods can be performed before, after, simultaneously, or between anyof the described methods. Further, the methods may be rearranged orreordered in other implementations. Also, the separation of varioussystem components in the implementations described above should not beunderstood as requiring such separation in all implementations, and itshould be understood that the described components and systems cangenerally be integrated together in a single product or packaged intomultiple products. Additionally, other implementations are within thescope of this disclosure.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include or do not include, certain features, elements,and/or steps. Thus, such conditional language is not generally intendedto imply that features, elements, and/or steps are in any way requiredfor one or more embodiments.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than or equal to 10% of, within less than or equal to 5% of, withinless than or equal to 1% of, within less than or equal to 0.1% of, andwithin less than or equal to 0.01% of the stated amount. If the statedamount is 0 (e.g., none, having no), the above recited ranges can bespecific ranges, and not within a particular % of the value. Forexample, within less than or equal to 10 wt./vol. % of, within less thanor equal to 5 wt./vol. % of, within less than or equal to 1 wt./vol. %of, within less than or equal to 0.1 wt./vol. % of, and within less thanor equal to 0.01 wt./vol. % of the stated amount.

Some embodiments have been described in connection with the accompanyingdrawings. The figures are drawn to scale, but such scale should not belimiting, since dimensions and proportions other than what are shown arecontemplated and are within the scope of the disclosed inventions.Distances, angles, etc. are merely illustrative and do not necessarilybear an exact relationship to actual dimensions and layout of thedevices illustrated. Components can be added, removed, and/orrearranged. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with various embodiments can be used in allother embodiments set forth herein. Additionally, it will be recognizedthat any methods described herein may be practiced using any devicesuitable for performing the recited steps.

While a number of embodiments and variations thereof have been describedin detail, other modifications and methods of using the same will beapparent to those of skill in the art. Accordingly, it should beunderstood that various applications, modifications, materials, andsubstitutions can be made of equivalents without departing from theunique and inventive disclosure herein or the scope of the claims.

What is claimed is:
 1. A delivery system for controlled deployment of acollapsible implant, the delivery system comprising: a handle at aproximal end of the delivery system, the handle comprising a tethercontrol knob configured to control movement of a tether extendingdistally away from the handle; and an outer hollow member operablyconnected to the handle configured to at least partially restrain theimplant in a collapsible configuration, wherein the tether extendsthrough the outer hollow member to engage the implant when the implantis positioned within the outer hollow member, the outer hollow memberbeing moveable relative to the implant to expose the implant at a bodylocation while the tether keeps the implant radially restrained; aninner shaft extending through the outer hollow member; a tetherretention member located on the inner shaft proximal to where the tetherengages the implant, the tether retention member configured to hold afree end of the tether; a locking shaft slidable over the inner shaftand the tether retention member; a block located within the handle andproximal of the tether control knob, the block attached to a proximalend of the locking shaft; wherein rotation of the tether control knob ina single direction initially unspools the tether for allowing radialexpansion of the implant; wherein after the radial expansion of theimplant, further rotation of the tether control knob in the singledirection translates a screw in the handle proximally to translate theblock and the locking shaft proximally away from the tether retentionmember to release the free end of the tether; and wherein after therelease of the free end of the tether, further rotation of the tethercontrol knob in the single direction retracts the tether proximallythrough the outer hollow member toward the handle and respools thetether.
 2. The delivery system of claim 1, wherein the tether isconfigured to unspool and spool in a cavity within the tether controlknob.
 3. The delivery system of claim 1, further comprising areplacement valve located within a distal portion of the outer hollowmember, wherein the tether wraps around the replacement valve to preventexpansion of the replacement valve.
 4. The delivery system of claim 1,wherein the tether retention member comprises a c-lock, the c-lockhaving a longitudinal slot covered by the locking shaft, the slotretaining the free end of the tether.
 5. The delivery system of claim 4,further comprising a centering ring on the locking shaft to center thelocking shaft within the outer hollow member, the centering ringcomprising at least one aperture through which the tether passes.
 6. Thedelivery system of claim 1, wherein the handle comprises an auditory orvisual indicator to provide a user a signal indicating a position of thetether.
 7. A delivery system for controlled deployment of a collapsiblereplacement heart valve, the delivery system comprising: a handlecomprising an outer housing and a generally tubular shaped sleighlocated at least partially within the outer housing and received withina proximal end of the outer housing, the sleigh having a hollowinterior; a first elongate shaft operably connected to the housing andconfigured to cover at least a proximal end of the collapsiblereplacement heart valve; a second elongate shaft located within thefirst elongate shaft and operably connected to the hollow interior ofthe sleigh at a proximal end of the second elongate shaft; a thirdelongate shaft located within the second elongate shaft and operablyconnected to the hollow interior of the sleigh at a proximal end of thethird elongate shaft; a fourth elongate shaft located within the thirdelongate shaft and having a nose cone on a distal end thereof, the nosecone configured to radially restrain a distal end of the collapsiblereplacement heart valve, the fourth elongate shaft is operably connectedto the hollow interior of the sleigh at a proximal end of the fourthelongate shaft; and a single flush port exposed outside of the handle,wherein the single flush port is fluidly connected to the first elongateshaft, the second elongate shaft, and the third elongate shaft; whereinthe sleigh is configured to translate relative to the housing from adistal to a proximal position, wherein translation of the sleigh fromthe distal to the proximal position translates the second, third, andfourth elongate shafts proximally in one motion so that the second,third, and fourth elongate shafts remain in the same position relativeto one another in the distal and proximal position during the in onemotion translation of the sleigh from the distal to the proximalposition; and wherein the handle comprises a sleigh lock configured toprevent motion of the sleigh upon activation of the lock.
 8. Thedelivery system of claim 7, further comprising a first shaft knobconfigured to translate the first elongate shaft distally andproximally, a second shaft knob configured to translate the secondelongate shaft distally and proximally, and a fourth shaft knobconfigured to translate the fourth shaft distally and proximally,wherein each of the shaft knobs can move their respective shaftsindependent of one another.
 9. The delivery system of claim 7, whereinthe sleigh extends proximally from the handle in the proximal position.10. A delivery system for controlled deployment of a collapsiblereplacement heart valve, the delivery system comprising: a handlecomprising an outer housing and a generally tubular shaped sleighlocated at least partially within the outer housing and received withina proximal end of the outer housing, the sleigh having a hollowinterior; a first elongate shaft operably connected to the housing andconfigured to cover at least a proximal end of the collapsiblereplacement heart valve; a first shaft knob configured to translate thefirst elongate shaft distally and proximally; a second elongate shaftlocated within the first elongate shaft and operably connected to thehollow interior of the sleigh at a proximal end of the second elongateshaft; a second shaft knob configured to translate the second elongateshaft distally and proximally; a third elongate shaft located within thesecond elongate shaft and operably connected to the hollow interior ofthe sleigh at a proximal end of the third elongate shaft; a fourthelongate shaft located within the third elongate shaft and having a nosecone on a distal end thereof, the nose cone configured to radiallyrestrain a distal end of the collapsible replacement heart valve, thefourth elongate shaft is operably connected to the hollow interior ofthe sleigh at a proximal end of the fourth elongate shaft; a fourthshaft knob configured to translate the fourth shaft distally andproximally, wherein each of the first shaft knob, the second shaft knob,and the fourth shaft knob are configured to move their respective shaftsindependent of one another; and a single flush port exposed outside ofthe handle, wherein the single flush port is fluidly connected to thefirst elongate shaft, the second elongate shaft, and the third elongateshaft; wherein the sleigh is configured to translate relative to thehousing from a distal to a proximal position, wherein translation of thesleigh from the distal to the proximal position translates the second,third, and fourth elongate shafts proximally in one motion so that thesecond, third, and fourth elongate shafts remain in the same positionrelative to one another in the distal and proximal position during thein one motion translation of the sleigh from the distal to the proximalposition.
 11. The delivery system of claim 10, wherein the handlecomprises a sleigh lock configured to prevent motion of the sleigh uponactivation of the lock.
 12. The delivery system of claim 10, wherein thesleigh extends proximally from the handle in the proximal position.